MAUDE Adverse Event Report: CAREFUSION, INC STATIC AND DYNAMIC COMPLIANCE; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number 22 E

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Results of investigation: the device was returned and evaluated by a carefusion factory service technician.The reported issue, of the sample pump being noisy and the gas was free flowing, was duplicated.The sample pump and the demand valve were replaced, which resolved the reported issue.The device was tested and passed to service specifications, then returned to the customer.The carefusion failure analysis laboratory performed a failure investigation on the suspect components but could not create the failure in the laboratory setting.A root cause of the reported failure could not be identified.The component was returned to the manufacturer for further evaluation.Upon receipt of the completed failure investigation, a supplemental report will be submitted.

Event Description

The customer reported getting low volumes, having a noisy sample pump and gas free flow.She also stated that they had a (b)(6) patient diagnosed with testicular cancer with bilateral lung masses that had one pulmonary function test (pft) a month, for four months, starting in (b)(6) 2015 and the last one was in (b)(6) 2015.In (b)(6) the pft was showing normal lung values.The following months showed decreasing diffusion and restricted volumes with the last diffusion showing 53% in (b)(6).The patient was receiving aggressive chemotherapy called bleomycin which has a side effect of decreased lung function.It was advised that the patient discontinue chemotherapy based on his pft results.However, the clinician was concerned after having multiple module replacements in the previous months and she doubted the reliability of the results.It is unknown what happened to the patient because the patient did not return after (b)(6) 2015.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5682314
• MDR Text Key: 46013469
• Report Number: 2031702-2016-00655
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22 E
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR